Senior SaMD Learning Architect for Regulated Development

TrulyHired; United States; On-site; USD 140,000 - 200,000; Full time

Job summary

TrulyHired is seeking a Principal Technical Curriculum Developer to lead learning programs for SaMD product development and QA. You will translate regulatory, quality, and systems engineering concepts into practical, role-based training for engineers, product managers, TPMs, and leadership.

The role focuses on establishing an embedded learning function supporting thousands of product development professionals and collaborating with regulatory and quality teams to ensure compliant, effective

Qualifications

• Bachelor's degree in a relevant field.
• 8+ years of experience in medical device software, healthcare technology, quality engineering, systems engineering, regulatory affairs, product development, technical program management, or technical learning.
• Experience in regulated industries, preferably healthcare, medical device, or SaMD environments.
• Strong understanding of software development lifecycle processes.
• Direct experience with requirements engineering, risk management, hazard analysis, traceability, verification and validation, technical documentation, design controls, quality systems.

Responsibilities

• Design and deliver learning programs for regulated product development teams across Oracle Health.
• Create onboarding, role-based learning paths, technical workshops, certifications, and continuous education programs.
• Develop scalable learning strategies to improve competency, productivity, compliance, and execution quality.
• Partner with leadership to identify capability gaps and organizational priorities; translate complex regulatory concepts into practical training.

Skills

Regulated healthcare software

Quality engineering

Systems engineering

Regulatory affairs

Technical program management

Instructional design

Adult learning principles

Education

Bachelor's degree in Engineering, Computer Science, Healthcare Technology, Regulatory Affairs, Quality, Education, Instructional Design, or related field

Job description

TrulyHired is seeking a Principal Technical Curriculum Developer to lead learning programs for SaMD product development and QA. You will translate regulatory, quality, and systems engineering concepts into practical, role-based training for engineers, product managers, TPMs, and leadership.

The role focuses on establishing an embedded learning function supporting thousands of product development professionals and collaborating with regulatory and quality teams to ensure compliant, effective